Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)
This study has been completed.
First Posted: April 2, 2009
Last Update Posted: October 12, 2017
Information provided by (Responsible Party):
Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory blood pressure measurement will be performed beginning on Day 7 of each treatment period following administration of the study drug.
|Blood Pressure Human Experimentation||Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
|Official Title:||Randomized, Placebo-Controlled, Double-Blind, Two-Way Crossover Study to Evaluate the Effects of Phenylephrine HCl Extended-Release Tablets 30 mg Compared to Placebo on Ambulatory Blood Pressure|
Resource links provided by NLM:
Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochlorideU.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax). [ Time Frame: 24 hours after final dose of each 7-day treatment period. ]Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.
|Study Start Date:||December 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Experimental: Phenylephrine HCl Extended-Release tablets 30 mg
Phenylephrine HCl Extended Release tablets 30 mg
Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg
Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.
Placebo Comparator: Placebo
Placebo taken twice daily (12 hours apart) for 7 days.
Contacts and Locations
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